Methimazole

Product NDC
49884-641
11-digit product format
498840641
Labeler code
49884
Product ID
49884-641_c6608bc7-3b0c-4760-a7a1-bcc5c200685d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
methimazole
Dosage form
TABLET
Route
ORAL
Labeler
Par Pharmaceutical, Inc.
Application
ANDA040350
Marketing category
ANDA
Marketing start
2000-03-29
Marketing end
2024-10-31
Substance
METHIMAZOLE
Active strength
10 mg/1
Pharmacologic classes
Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
42f09d00-d445-e29e-bea8-dfb46b9366fcProduct name420251118
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-641-01EA - Each49884-6418aeb964a-9f14-4a6c-b2b5-fe2c251c9a6c12012-07-24
49884-641-05EA - Each49884-6418a6c5d17-03e7-4528-a7d5-4425223de53b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
METHIMAZOLEACTIVE INGREDIENT554Z48XN5EMETHIMAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]4
METHIMAZOLEACTIVE MOIETY554Z48XN5EMETHIMAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETHIMAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHIMAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETHIMAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]4
TALCINACTIVE INGREDIENT7SEV7J4R1UMETHIMAZOLE TABLET [PHYSICIANS TOTAL CARE, INC.]4
METHIMAZOLEACTIVE INGREDIENT554Z48XN5EMETHIMAZOLE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
METHIMAZOLEACTIVE INGREDIENT554Z48XN5EMETHIMAZOLE TABLET [REBEL DISTRIBUTORS CORP.]1
METHIMAZOLEACTIVE MOIETY554Z48XN5EMETHIMAZOLE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
METHIMAZOLEACTIVE MOIETY554Z48XN5EMETHIMAZOLE TABLET [REBEL DISTRIBUTORS CORP.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETHIMAZOLE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMETHIMAZOLE TABLET [REBEL DISTRIBUTORS CORP.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHIMAZOLE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30METHIMAZOLE TABLET [REBEL DISTRIBUTORS CORP.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETHIMAZOLE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMETHIMAZOLE TABLET [REBEL DISTRIBUTORS CORP.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UMETHIMAZOLE TABLET [REBEL DISTRIBUTORS CORP.]1
TALCINACTIVE INGREDIENT7SEV7J4R1UMETHIMAZOLE TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197941methIMAzole 10 MG Oral TabletPSN4d42cebc-5d3e-4b88-883f-5875b83a55154
197942methIMAzole 5 MG Oral TabletPSN4d42cebc-5d3e-4b88-883f-5875b83a55154
197941methimazole 10 MG Oral TabletSCD4d42cebc-5d3e-4b88-883f-5875b83a55154
197942methimazole 5 MG Oral TabletSCD4d42cebc-5d3e-4b88-883f-5875b83a55154
197941thiamazole 10 MG Oral TabletSY4d42cebc-5d3e-4b88-883f-5875b83a55154
197942thiamazole 5 MG Oral TabletSY4d42cebc-5d3e-4b88-883f-5875b83a55154
197941methIMAzole 10 MG Oral TabletPSN0c0617f2-cc3f-4fd5-a7cf-564ec1445e461
197941methIMAzole 10 MG Oral TabletPSN74238d87-5f82-4a5e-a920-a9fc68115e911
197942methIMAzole 5 MG Oral TabletPSN74238d87-5f82-4a5e-a920-a9fc68115e911
197941methimazole 10 MG Oral TabletSCD0c0617f2-cc3f-4fd5-a7cf-564ec1445e461
197941methimazole 10 MG Oral TabletSCD74238d87-5f82-4a5e-a920-a9fc68115e911
197942methimazole 5 MG Oral TabletSCD74238d87-5f82-4a5e-a920-a9fc68115e911
197941thiamazole 10 MG Oral TabletSY0c0617f2-cc3f-4fd5-a7cf-564ec1445e461
197941thiamazole 10 MG Oral TabletSY74238d87-5f82-4a5e-a920-a9fc68115e911
197942thiamazole 5 MG Oral TabletSY74238d87-5f82-4a5e-a920-a9fc68115e911

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49884-641-0149884064101100 TABLET in 1 BOTTLE (49884-641-01) 100 tablet2015-09-280000-00-00NoNoCurrent
49884-641-0549884064105500 TABLET in 1 BOTTLE (49884-641-05) 500 tablet2015-09-280000-00-00NoNoCurrent